Kornimate/medical-research-clean huggingface dataset:
preoperative nebulized dexmedetomidine on hemodynamic changes in laparoscopic bariatric surgery.

Conditions: Dexmedetomidine; Hemodynamics; Laparoscopic Bariatric Surgery

Summary: this randomized study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation and pneumoperitoneum in morbidly obese patients undergoing laparoscopic bariatric surgery.

dexmedetomidine is an α -2 adrenergic agonist that has been proven to attenuate the hemodynamic response to intubation and pneumoperitoneum along with dose sparing effect on opioids and propofol .it has been used in multiple routes such as intravenous, intramuscular, oral, nasal, or intrathecal routes .inhalation of nebulized drug is noninvasive and associated with high bioavailability .nebulized dexmedetomidine may offer an attractive alternative to both intravenous as well as intranasal routes of administration because drug deposition following nebulization takes place over nasal, buccal, as well as respiratory mucosa.

Eligibility criteria:
inclusion criteria: * this study will include 90 adult morbidly obese patients of both sex with bmi (40-50), (asa) iii physical status, aged between 18 -50 years scheduled for elective laparoscopic bariatric surgery under general anesthesia. exclusion criteria: 1. patient's refusal. 2. decompensated hepatic or renal or cardiac disease. 3. expected difficult airway management. 4. uncontrolled hypertension. 5. psychiatric disease. 6. sever pulmonary disorders. 7. patients on opioid, alcohol, beta-blockers or allergy to any of the study drugs.
study for the development and validation of chronic cough patient perspective questionnaire

Conditions: Chronic Cough

Summary: starting from chronic cough impact querstionnaire (cciq), of which we are the authors and copyright holders, it will be developed and validated a shortened version with psychometric properties allowing the use in the evaluation of single patient (chronic cough patient perspective). the ccpp will allow to unmask the problem, reduce underdiagnosis, increase awareness on chronic cough, measure the impact of the chronic cough and its treatments on the patient's life.


Eligibility criteria:
inclusion criteria: diagnosis of rcc (residual cough vas:\>10/100 mm) according to ers guidelines exclusion criteria: difficulty in understanding the italian language in both spoken and written form
elimination of ptv margins based on online adaptive stereotactic radiotherapy for early-stage non-small cell lung cancer or pulmonary oligometastases

Conditions: Adaptive Radiotherapy; Stereotactic Body Radiotherapy; Non-small Cell Lung Cancer; Lung Oligometastases; Toxicity

Summary: this study aims to explore the safety and efficacy of eliminating the ptv (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with early-stage non-small cell lung cancer (nsclc) or pulmonary oligometastases.

this study aims to explore the safety and efficacy of eliminating the ptv expansion margin based on online adaptive stereotactic body radiotherapy (sbrt) for early-stage non-small cell lung cancer (nsclc) or pulmonary oligometastases. in this study, patients will be stratified according to whether they have primary early-stage nsclc, then randomly assigned in a 1:1 ratio to the study group or the control group. patients in the study group will receive online adaptive sbrt (without ptv expansion margin), while patients in the control group will receive conventional standard sbrt. after the completion of treatment, patients will be followed up regularly to assess safety and efficacy.

Eligibility criteria:
inclusion criteria: * histologically or pet-ct confirmed untreated early-stage non-small cell lung cancer (t1-2n0m0) that is inoperable or where the patient is unwilling to undergo surgery, or pet-ct/chest ct confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm). * age 18 years or older, regardless of gender. * ecog performance status score of 0-2. * serum hemoglobin ≥ 80 g/l, platelets ≥ 100,000/μl, absolute neutrophil count ≥ 1,500/μl. * serum creatinine ≤ 1.25 times the upper normal limit (unl) or creatinine clearance ≥ 60 ml/min. * serum bilirubin ≤ 1.5 times unl, ast (sgot) and alt (sgpt) ≤ 2.5 times unl, alkaline phosphatase ≤ 5 times unl. * fev1 ≥ 0.5 l. * normal cb6 range. * the patient and their family agree and sign the informed consent form. exclusion criteria: * tumors with bronchial invasion are excluded. * any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias). * pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals. * individuals with substance abuse issues, chronic alcoholism, or aids. * individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders. * individuals with a history of severe allergies or specific sensitivities.

Keywords: online adaptive radiotherapy stereotactic body radiotherapy non-small cell lung cancer lung oligometastases toxicity
to evaluate current efficacy of antimalarials used in timika, papua, indonesia

Conditions: Falciparum Malaria; Vivax Malaria

Summary: multidrug resistant strains of p.falciparum and p.vivax are becoming increasingly prevalent in the asia pacific rim. to determine the efficacy of locally recommended antimalarial protocols in papua, indonesia, consecutive patients presenting to a rural clinic were enrolled into a prospective efficacy study. patients with uncomplicated falciparum malaria were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria with chloroquine monotherapy. patients failing therapy received unsupervised oral quinine +/- doxycycline for 7 days. follow-up was continued for 42 days for falciparum malaria and 28 days for vivax malaria. the study hypothesis was that current recommended antimalarial protocols were no longer effective.


Eligibility criteria:
inclusion criteria: -male and female patients at least one 1year of age and weighing more than 10kg. * -microscopic confirmation of p. falciparum and /or p.vivax infection (any parasitaemia). * -fever (axillary temperature \>37.5oc) or history of fever in the last 48 hours. * -able to participate in the trial and comply with the clinical trial protocol * -written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent exclusion criteria: * pregnancy or lactation * -inability to tolerate oral treatment * -signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment * -known hypersensitivity or allergy to artemisinin derivatives * -serious underlying disease (cardiac, renal or hepatic) * -parasitaemia \>4%

Keywords: falciparum vivax papua chloroquine sulphadoxine-pyrimethamine
evaluation of hydroxychloroquine to prevent cipn

Conditions: Breast Cancer; Gynecologic Cancer; Early-stage Breast Cancer; Peripheral Neuropathy; Chemotherapy-induced Peripheral Neuropathy

Summary: the study is being done to research if hydroxychloroquine can prevent chemotherapy induced peripheral neuropathy. certain chemotherapy drugs, like paclitaxel, are known to cause neuropathy which can impact quality of life. currently, there are no options for preventing peripheral neuropathy. in addition, there are no useful methods to assess peripheral nerve damage. this study will also explore using a study mri of patients' feet prior to starting chemotherapy and after they have completed chemotherapy to see if there is any difference in their nerve structure.


Eligibility criteria:
inclusion criteria: * patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent * age ≥ 21 years old * no prior neurotoxic chemotherapies * no other neurotoxic chemotherapies planned during paclitaxel treatment (i.e, platinum) * need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician * be able to undergo mr imaging * be willing to comply with scheduled visits, treatment plan, and mr imaging * adequate organ function as defined as: hematologic: absolute neutrophil count (anc) ≥ 1500/mm3 platelet count ≥ 100,000/mm3 hemoglobin ≥ 9 g/dl hepatic: total bilirubin ≤ 1.5x institutional upper limit of normal (uln) ast(sgot)/alt(sgpt) ≤ 3 × institutional uln renal: estimated creatinine clearance (crcl)≥ 50 ml/min by cockcroft-gault formula exclusion criteria: * stage iv cancer * ctcae neurological function \> grade 1 at baseline * mental limitation that precludes understanding of or completion of questionnaires * history of diabetes or other neurological disorders * preexisting peripheral neuropathy * prior exposure to neurotoxic chemotherapy * currently taking medication to treat or prevent neuropathy * have non-mri compatible metallic objects on/in body * have metallic hardware in the lower extremity which is mr compatible however would create too much artifact for mr examination * pregnant or lactating patients. women of childbearing potential and sexually active men must use an effective contraception method during rreatment and for three months after completing treatment. patients of childbearing potential must have a negative serum or urine b-hcg pregnancy test at screening. * history or current evidence of central serous retinopathy (csr) or retinal vein occlusion (rvo) or current risk factors for rvo (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity) or macular degeneration. * qtc prolongation defined as a qtcf \> 500 ms * known glucose-6-phosphate dehydrogenase (g-6-pd) deficiency.

Keywords: chemotherapy induced peripheral neuropathy hydroxycloroquine diffusion tensor imaging breast cancer gynecologic cancer paclitaxel neoadjuvant chemotherapy
adaptive servo-ventilation monitoring study

Conditions: Chronic Heart Failure

Summary: sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. adaptive servo-ventilation (asv) can be used to treat sleep apnea in these patients. this is an observational study to document changes in respiratory parameters in hf patients using asv for a period of 12 months.


Eligibility criteria:
inclusion criteria: more than 18 years old chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines nyha class iii or iv at the time of inclusion with at least one hospitalization for heart failure in the last 12 months moderate to severe sleep apnea (ahi ≥ 15/hour). already using or willing to use asv-therapy and able to tolerate the mask treatment exclusion criteria: planned or scheduled heart valve interventions and/or cabg untreated or therapy refractory restless leg syndrome patients for whom the use of positive airway pressure therapy may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum pregnancy
interventional study of vosoritide for the treatment of children with hypochondroplasia

Conditions: Hypochondroplasia

Summary: the intent and design of this phase 3 study is to assess vosoritide as a therapeutic option for the treatment of children with hypochondroplasia (hch).

this is a phase 3 randomized, stratified, placebo-controlled, double-blind multicenter study to evaluate the effect of 52 weeks of daily vosoritide administration on annualized growth velocity (agv) in participants with hch. eligible participants with documented hch confirmed by genetic testing will roll over from study 111-902 and enter the 111-303 study. participants will be randomly assigned to one of two treatment groups: placebo or vosoritide. the route of administration is subcutaneous injection, and the frequency of administration is daily.

Eligibility criteria:
inclusion criteria: 1. participants must be ≥ 3 to \< 18 years of age at enrollment 2. a confirmed genetic diagnosis of hch 3. a height z score of ≤ - 2.0 standard deviations (sds) in reference to the general population of the same age and sex, as calculated using the center for disease control and prevention (cdc) growth charts 4. males and females are eligible to participate in this clinical study. 5. females ≥ 10 years old or who have begun menses must have a negative pregnancy test at the screening visit and be willing to have additional pregnancy tests during the study. 6. if sexually active, participants must be willing to use a highly effective method of contraception while participating in the study. exclusion criteria: 1. short stature condition other than hch 2. have an unstable condition likely to require surgical intervention during the study. 3. evidence of decreased growth velocity and/or growth plate closure 4. taking any of the prohibited medications 5. treated with growth hormone, insulin-like growth factor 1 (igf-1), or anabolic steroids 6. planned or expected to have limb-lengthening surgery during the study period. 7. planned or expected bone-related surgery (ie, surgery involving disruption of bone cortex, excluding tooth extraction), during the study period 8. require any investigational agent prior to completion of study period. 9. received vosoritide or another investigational product or investigational medical device in the past 10. have used any investigational product or investigational medical device for the treatment of hch or short stature at any time, including vosoritide 11. have current malignancy, history of malignancy, or currently under work-up for suspected malignancy. 12. have known hypersensitivity to vosoritide or its excipients. 13. concurrent disease or condition that, in the view of the investigator, would interfere with study participation or safety evaluations, for any reason.

Keywords: hypochondroplasia dwarfism bone diseases bone disease, developmental hch natriuretic peptide, c-type musculoskeletal diseases natriuretic agents physiological effects of drugs skeletal dysplasias genetic diseases, inborn osteochondrodysplasias vosoritide voxzogo
safety and efficacy study of alfimeprase in subjects with occluded catheters

Conditions: Thrombosis; Venous Thrombosis; Catheter Occlusion

Summary: to evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.

further study details as provided by nuvelo

Eligibility criteria:
inclusion criteria: * must give written informed consent * ages 18 or older * unable to withdraw at least 3 ml of blood from a central venous access device * hemodynamically stable * available for follow-up assessments exclusion criteria: * inability to infuse at least 2 ml of saline through the catheter * catheter placed less than 48 hours prior to detection of occlusion * catheter used for hemodialysis or pheresis * previous treatment with plasminogen activator for current episode of catheter occlusion * less than 18 years of age * any evidence of mechanical or nonthrombotic occlusion * in the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard * increased risk for drug extravasation * pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g., intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator) * known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect * participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit * any other subject feature that in the opinion of the investigator should preclude study participation

Keywords: occluded central venous access devices occluded catheters thrombosis thrombosis, catheter alfimeprase thrombotic occlusion thrombosis, cvad thrombosis, catheters
study evaluating the efficacy and safety of etanercept and methotrexate in japanese subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.


Eligibility criteria:
inclusion criteria: * must be japanese and live in japan * must be age 20 to 75 years * diagnosed less than or equal to 10 years from time of first visit exclusion criteria: * anyone who has received etanercept or tnf-inhibitors such as infliximab or adalimumab in the past * patient with other rheumatic diseases or conditions that could predispose the patient to infection * pregnant or lactating women

Keywords: rheumatoid arthritis arthritis
the utility of next-generation sequencing for the diagnosis of periprosthetic joint infection

Conditions: Prosthetic Joint Infection

Summary: this is a prospective multicenter study. all patients presenting for revision hip or knee arthroplasty for all indications under the respective surgeon's care may be eligible. per standard of care preoperatively, all patients must have blood drawn for erythrocyte sedimentation rate(esr), c-reactive protein(crp) and d-dimer. aspiration of the joint in question may be performed at the discretion of the treating surgeon and results documented. intraoperative samples will also be collected and sent for ngs analysis

pre-operative d-dimer testing should be performed if this is in keeping with the local institutional standard of care. otherwise, d-dimer testing will be omitted from the pre-operative panel of tests collected. ngs results will be made available to the investigator. treatment will remain within keeping with the investigator's standard of care. ngs results may be used at the discretion of the treating surgeon in guiding patient treatment.

Eligibility criteria:
inclusion criteria: 1. patients undergoing primary total hip or knee arthroplasty with no history of prior surgery 2. patients undergoing revision hip or knee arthroplasty for septic or aseptic indication. exclusion criteria: 1. patients undergoing second stage re-implantation surgery for pji.
study on the phenotype of language in preterm born children at 5 years of age

Conditions: Preterm Children

Summary: in recent years, several studies confirm that some of preterm children have language developmental disabilities, in production, in comprehension, or in written language. these language impairments lead to learning disabilities. there are, however, contradictions concerning the origin and nature of language dysfunctions. some studies find lexical disorders (number of words used by the child), others preferentially phonological disorders (sounds used in the language), others also disorders of the morphosyntaxe (organization of the sentences) and fragilities that affect pragmatics (understanding situations). the computer-evaluation of the language is carried out at five and a half year coupled with the medical and neuropsychological examinations. the language assessment lasts 30 to 45 minutes per child. it is carried out using a laptop computer that allows the submission of stimuli and recording of the child's responses. the language evaluation scale is the battery cléa (pasquet f et al, 2014), standardized reference tool for the realization of a language evaluation. the assessment includes three tests: comprehension of words and phrases, production of words and phrases, and judgment of sentences. each time, the child sees images and hears words or phrases. sometimes he has to say what he sees on the computer screen. as usual, a speech-language assessment is not carried out, routinely, at the age of 5 years in the context of the follow-up of children born very preterm. the evaluation proposed to the child in this research will be carried out at a significant period of development, before writing. this assessment will not only assess the structure of the child's language, but also determine if there are possible difficulties in learning to read and write. the expected benefits for the health of the children included in the trial therefore concern the detection or characterization of any developmental fragilities affecting the language. these screenings or characterizations will make it possible to advocate a speech rehabilitation if necessary.


Eligibility criteria:
inclusion criteria: * children born very preterm in 2011 in the region of haute-normandie in france exclusion criteria: * none
targeting cd19/cd20 dual-targeted cell in patients with relapsed/refractory b-cell non-hodgkin lymphoma

Conditions: B-Cell Non-Hodgkin Lymphoma-Recurrent; B-Cell Non-Hodgkin Lymphoma-Refractory

Summary: a phase i, open-label clinical study to evaluate the safety, tolerability, and efficacy of lucar-g39d, a dual-targeted cell preparation targeting cd19/cd20, in patients with relapsed/refractory b-cell non-hodgkin lymphoma.

this is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of lucar-g39d in the patient ≥ 18 years of age with relapsed or refractory b-cell non-hodgkin lymphoma. subjects who meet the eligibility criteria will receive a single dose of lucar-g39d injection. the study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Eligibility criteria:
inclusion criteria: 1. subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent. 2. aged 18-75 years (inclusive). 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. histologically confirmed b-cell non-hodgkin lymphoma that expresses at least one of cd19/cd20. 5. at least one evaluable tumor lesion according to lugano 2014 criteria. response to prior therapy is consistent with one of the following: 1. primary refractory. 2. relapsed or refractory after 2 or more lines of therapy. 3. for lbcl, 3b fl. t-inhl: * relapse within 12 months after first-line chemoimmunotherapy to achieve cr; * progression or relapse within 12 months after autologous hematopoietic stem cell transplantation; 7. life expectancy≥ 3 months 8. clinical laboratory values meet screening visit criteria exclusion criteria: subject eligible for this study must not meet any of the following criteria: 1. prior antitumor therapy with insufficient washout period ; 2. patients who received autologous car-t cell therapy (except cd19-targeted) or autologous gene therapy; 3. patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. patients who are positive for any index of hepatitis b surface antigen (hbsag), hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis c antibody (hcv-ab), hepatitis c virus ribonucleic acid (hcv rna), or human immunodeficiency virus antibody (hiv- ab). 6. known life-threatening allergies, hypersensitivity, or intolerance to lucar-g39d car-t cell or its excipients, including dmso. 7. pregnant or lactating women;